Quality Review of Documents Product Information Templates
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Quality Review of Documents Product Information Template
Clinical efficacy and safety
Identifier
200000029825
Term Name
en
bg
cs
da
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fi
fr
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hr
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lt
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Clinical efficacy and safety
Translation Status
CURRENT
Modified on
2024-08-27
Status
CURRENT
Domain
Human use - H
Parent
5.1 Pharmacodynamic properties
Hierarchy
Clinical efficacy and safety
(level=H4)
/
5.1 Pharmacodynamic properties
(level=H3)
/
5. PHARMACOLOGICAL PROPERTIES
(level=H2)
/
SUMMARY OF PRODUCT CHARACTERISTICS
(level=H1)
Data Classification
PUBLIC
Extended Attributes
Is blank subsection allowed
Y
Is Mandatory
N
Product Information Document Type
Summary of Product Characteristics - smpc
Regulatory Authorisation/Registration Procedure
Centralised Procedure - CP
Regulatory Authorisation/Registration Procedure
Decentralised Procedure - DCP
Regulatory Authorisation/Registration Procedure
Mutual Recognition Procedure - MRP
Regulatory Authorisation/Registration Procedure
National Procedure - NP
Sequence Order
35